FDA Inspection 1285196 — EuropTec Polymer AG
The FDA completed an inspection of EuropTec Polymer AG on September 25, 2025 in Oftringen. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 25, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Oftringen (Switzerland)
Citations
| ID | CFR | Description |
|---|---|---|
| 3175 | 21 CFR 820.186 | QSR |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |